ABLAVAR® - Imaging Guidelines

ABLAVAR^®imaging is completed in two stages: the first-pass (dynamic) imaging stage and the steady-state (equilibrium) imaging stage. Both stages are essential for adequate evaluation of the arterial system, and dynamic imaging always precedes steady-state imaging. During interpretation of the steady-state images, ABLAVAR^® within the venous system may limit or confound the detection of arterial lesions.

To assess the initial distribution of ABLAVAR^® within the arterial system, begin dynamic imaging immediately upon injection. Begin steady-state imaging after dynamic imaging has been completed, generally 5 to 7 minutes following ABLAVAR^®administration. At this time point, ABLAVAR^®is generally distributed throughout the blood. In clinical trials, steady-state imaging was completed within approximately 1 hour following ABLAVAR^®injection.

The ABLAVAR^®bolus may be administered manually or by power injector.

Because ABLAVAR^®is effective at a low dose, a slow injection rate (1.0 mL/sec) followed by a standard saline flush is recommended.^1,2,3

Please note that ABLAVAR^®is intended for single-use only and should be used immediately upon opening. Discard any unused portion of the ABLAVAR^®vial.

Reference

1. ABLAVAR^® [package insert]. North Billerica, MA: Lantheus Medical Imaging, Inc.; 2011. 2. Leiner T, Goyen M, Rohrer M, Schönberg S, eds. Clinical Blood Pool MR Imaging. Heidelberg, Germany: Springer Medizin Verlag; 2008:96. 3. Perreault, P, Edelman M, et al. MR Angiography with Gadofosveset Trisodium for Peripheral Vascular Disease: Phase II Trial. Radiology. 2003;229:811-820.

INDICATIONS:

ABLAVAR^® is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

CONTRAINDICATIONS:

History of a prior allergic reaction to a gadolinium-based contrast agent.

IMPORTANT SAFETY INFORMATION:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk for NSF appears highest among patients with:

chronic, severe kidney disease (GFR < 30 mL/min/1.73m²), or
acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

ABLAVAR^® Injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other gadolinium based contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function.

In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes following ABLAVAR^® administration. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for arrhythmias due to baseline QTc prolongation.

Have emergency resuscitative equipment available prior to and during ABLAVAR^® administration.

Please see full Prescribing Information, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF).